FDA Adverse Event
Malfunction
Summary report: N
FAST-CASH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F
MDR report key: 2142128
·
Received May 26, 2011
Report
- Report Number
- 3005188751-2011-00062
- Event Type
- Malfunction
- Date Received
- May 26, 2011
- Date of Event
- May 5, 2011
- Report Date
- May 5, 2011
- Manufacturer
- ST. JUDE MEDICAL, AF DIVISION
- Product Code
- DYB
- PMA / PMN Number
- K061015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WE ARE AWAITING DEVICE RETURN. IF THE DEVICE IS RECEIVED FOR EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED A LEAK WAS NOTED AT THE END OF THE SHEATH DURING THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FAST-CASH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F | SWARTZ TRANSSEPTAL SL1 | DYB | ST. JUDE MEDICAL, AF DIVISION | 406840 | 3173892 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |